HydrALAZINE Hydrochloride Tablets Recalled for Out-of-Specification Impurities
HydrALAZINE Hydrochloride Tablets Lot T04680 are recalled for out-of-specification impurities found during routine testing. No illnesses have been reported, but the product poses a remote risk of reversible effects.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class II recall involves out-of-specification impurities in a pharmaceutical product. However, no illnesses or injuries have been reported, and the risk is described as remote with only reversible or transient effects possible, placing it in the Moderate rather than Severe category.
Plain-English summary
HydrALAZINE Hydrochloride Tablets, USP 10mg, in 100-count blister card packaging (Lot T04680, expiration 6/2024) are being recalled.
The recall was initiated after routine stability testing identified out-of-specification impurity levels in the product. While there is a remote possibility that these impurities could cause medically reversible or transient adverse effects, no illnesses or injuries have been reported.
The affected product was distributed nationwide throughout the United States. Approximately 8,198 units are involved in the recall. The product was manufactured for Heritage Pharmaceuticals, Inc., Eatontown, NJ, and distributed by Major Pharmaceuticals, Livonia, MI.
Patients currently using this medication should contact their healthcare provider or pharmacist to discuss this recall and appropriate next steps. Do not discontinue the medication without consulting a healthcare provider.
The recalled product
- Product
- HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
- Category
- Drug
- Hazard
- Affected units
- 8,198
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: T04680
- Exp. Date 6/2024
Distribution
Distributed nationwide across the United States.
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